MAUDE Adverse Event Report: ABBOTT VASCULAR HI-TORQUE EXTRA S'PORT GUIDE WIRE WITH MICROGLIDE COATING

Catalog Number	22225M
Medical Device Problem Codes	Product Quality Problem (1506); Difficult to Remove (1528); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
It was reported that during use of the.014 sport extra guide wire (gw) felt heavier.The teflon coating felt different and the color looked different than normal.It was also noted that the gw felt tacky and it was more difficult to remove balloons and stents when exchanging devices, which caused the gw to back out of the vessel.The procedure was completed with the same gw, but the gw had to be wiped down several times during use.There was no adverse patient effect and no clinically significant delay reported in the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history of the reported lot did not indicate a lot specific quality issue.The investigation was unable to determine a conclusive cause for the reported difficulties.In this case, it was reported that the teflon coating had an irregular texture and appearance.Our manufacturing team confirmed that the teflon supplier, formulation, and manufacturing process have not changed in the past 2 years.Factors that may contribute to an irregular handling, texture, or appearance include, but are not limited to, damage incurred during manufacturing, damage incurred during shipment, inadvertent damage during unpacking, material properties or procedure contaminants.Additionally, factors that may contribute to difficulty removing devices over the guide wire include, but are not limited to, inner diameter of the device, outer diameter of the guide wire, device support, buildup of procedural contaminants, user technique, and/or damage to the device or guide wire.Based on the information provided and because the device was not returned for analysis, it is unknown what may have caused the reported difficulties.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• Brand Name: HI-TORQUE EXTRA S'PORT GUIDE WIRE WITH MICROGLIDE COATING
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 2024168; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 18440248
• Report Number: 2024168-2024-00114
• Device Sequence Number: 6959186
• Product Code: DQX
• UDI-Device Identifier: 08717648079573
• UDI-Public: 08717648079573
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K950156
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2024
• Device Catalogue Number: 22225M
• Device Lot Number: 2040161
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/12/2023
• Supplement Date Received by Manufacturer: 01/26/2024
• Initial Report FDA Received Date: 01/03/2024
• Supplement Report FDA Received Date: 02/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown